Disproportionality Analysis and Characterisation of Medication Errors in EudraVigilance: Exploring Findings on Sexes and Age Groups.

Background: While medication errors (MEs) have been studied in the European Medicines Agency's EudraVigilance, extensive characterisation and signal detection based on sexes and age groups have not been attempted.

Objectives: The aim of this study was to characterise all ME-related individual case safety reports in EudraVigilance and explore notable signals of disproportionate reporting (SDRs) among sexes and age groups for the 30 most frequently reported drugs.

Methods: Individual case safety reports were used from EudraVigilance reported between 2002 and 2021.

Parasitic infections related to anti-type 2 immunity monoclonal antibodies: a disproportionality analysis in the food and drug administration's adverse event reporting system (FAERS).

Monoclonal antibodies (mAbs) targeting immunoglobulin E (IgE) [omalizumab], type 2 (T2) cytokine interleukin (IL) 5 [mepolizumab, reslizumab], IL-4 Receptor (R) α [dupilumab], and IL-5R [benralizumab]), improve quality of life in patients with T2-driven inflammatory diseases. However, there is a concern for an increased risk of helminth infections. The aim was to explore safety signals of parasitic infections for omalizumab, mepolizumab, reslizumab, dupilumab, and benralizumab.

Supporting Pharmacovigilance Signal Validation and Prioritization with Analyses of Routinely Collected Health Data: Lessons Learned from an EHDEN Network Study.

Introduction: Individual case reports are the main asset in pharmacovigilance signal management. Signal validation is the first stage after signal detection and aims to determine if there is sufficient evidence to justify further assessment. Throughout signal management, a prioritization of signals is continually made.

Comorbidity in incident osteoarthritis cases and matched controls using electronic health record data.

Background: Comorbidities are common in patients with osteoarthritis (OA). This study aimed to determine the association of a wide range of previously diagnosed comorbidities in adults with newly diagnosed OA compared with matched controls without OA.

Methods: A case-control study was conducted.

Epidemiology of chronic inflammatory demyelinating polyradiculoneuropathy in The Netherlands.

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a rare but disabling disorder that often requires long-term immunomodulatory treatment. Background incidence rates and prevalence and risk factors for developing CIDP are still poorly defined. In the current study, we used a longitudinal population-based cohort study in The Netherlands to assess these rates and demographic factors and comorbidity associated with CIDP.

Incidence and Prevalence of Knee Osteoarthritis Using Codified and Narrative Data From Electronic Health Records: A Population-Based Study.

Objective: To determine the incidence and prevalence of knee osteoarthritis (OA) using codified and narrative data from general practices throughout The Netherlands.

Methods: This retrospective cohort study was conducted using the Integrated Primary Care Information database. Patients with codified knee OA were selected, and an algorithm was developed to identify patients with narratively diagnosed knee OA only.

Antidepressant and anticonvulsant prescription rates in patients with osteoarthritis: a population-based cohort study.

Objectives: There are signs that antidepressants and anticonvulsants are being prescribed more often for OA patients, despite limited evidence. Our objectives were to examine prescription rates and time trends for antidepressants and anticonvulsants in OA patients, to assess the percentage of long-term prescriptions, and to determine patient characteristics associated with antidepressant or anticonvulsant prescription.

Methods: A population-based cohort study was conducted using the Integrated Primary Care Information database.

Opioid prescriptions in patients with osteoarthritis: a population-based cohort study.

Objectives: To examine the incidence, prevalence and trends for opioid prescriptions in patients with OA. Furthermore, types of opioids prescribed and long-term prescription rates were examined. Finally, the patient characteristics associated with the prescription of opioids were assessed.

The association of vascular disorders with incident dementia in different age groups.

Background: There is increasing evidence that dementia risk associated with vascular disorders is age dependent. Large population-based studies of incident dementia are necessary to further elucidate this effect. Therefore, the aim of the present study was to determine the association of vascular disorders with incident dementia in different age groups in a large primary care database.

Identifying Data Elements to Measure Frailty in a Dutch Nationwide Electronic Medical Record Database for Use in Postmarketing Safety Evaluation: An Exploratory Study.

Introduction: The role of frailty in postmarketing drug safety is increasingly acknowledged. Few European electronic medical records (EMRs) have been used to explore frailty in observational drug safety research.

Objective: The aim of this study was to identify data elements, beyond multimorbidity and polypharmacy, that could potentially contribute to measuring frailty among older adults in the Dutch nationwide Integrated Primary Care Information (IPCI) database.

Translation of clinical prediction rules for febrile children to primary care practice: an observational cohort study.

Background: Clinical prediction rules (CPRs) to identify children with serious infections lack validation in low-prevalence populations, which hampers their implementation in primary care practice.

Aim: To evaluate the diagnostic value of published CPRs for febrile children in primary care.

Design And Setting: Observational cohort study among febrile children (<16 years) who consulted five GP cooperatives (GPCs) in the Netherlands.

Alarming signs and symptoms in febrile children in primary care: an observational cohort study in The Netherlands.

Context: Febrile children in primary care have a low risk for serious infection. Although several alarming signs and symptoms are proposed to have predictive value for serious infections, most are based on research in secondary care. The frequency of alarming signs/symptoms has not been established in primary care; however, in this setting differences in occurrence may influence their predictive value for serious infections.

Alarm signs and antibiotic prescription in febrile children in primary care: an observational cohort study.

Background: Although fever in children is often self-limiting, antibiotics are frequently prescribed for febrile illnesses. GPs may consider treating serious infections by prescribing antibiotics.

Aim: To examine whether alarm signs and/or symptoms for serious infections are related to antibiotic prescription in febrile children in primary care.

Is OpenSDE an alternative for dedicated medical research databases? An example in coronary surgery.

Background: When using a conventional relational database approach to collect and query data in the context of specific clinical studies, a study with a new data set usually requires the design of a new database and entry forms. OpenSDE (SDE = Structured Data Entry) is intended to provide a flexible and intuitive way to create databases and entry forms for the collection of data in a structured format. This study illustrates the use of OpenSDE as a potential alternative to a conventional approach with respect to data modelling, database creation, data entry, and data extraction.

Generic computer-based questionnaires: an extension to OpenSDE.

Development of computer-based questionnaires (CQs) has been an ongoing challenge since the 1960s. The added value of such CQs for data collection and the acceptance by patients have been well documented. Many questionnaire projects, however, were temporary due to dedicated software, limited funding, and lack of integration with medical information systems.

OpenSDE: Row modeling applied to generic structured data entry.

Clinicians generally record medical narrative data, such as current complaints, physical examination, and progress notes, as free text in paper-based medical records. The medical narrative involves heterogeneous and detailed data that include the description of (multiple) occurrences of medical findings or symptoms that may progress over time. Structured, electronic recording of narrative data would facilitate the use of these data for research.